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Ultra Glow Fade by Keystone Laboratories

Medically reviewed on January 10, 2018

Dosage form: cream
Ingredients: HYDROQUINONE 1g in 51g
Labeler: Keystone Laboratories
NDC Code: 58318-003

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

2% Hydroquinone ..... Skin Lightener

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Skin lightener

Ultra Glow Fade Cream

2% Hydroquinone  ......  Skin Lightener

Warnings:

For external use only. Children under 12 years of age: Do not use unless directed by a doctor. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor. Avoid contact with eyes, rinse with water to remove. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin during and after treatment is completed in order to prevent darkening from reoccurring. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Adults: Apply a small amount in a thin layer on the affected area twice daily or as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable on very dark skin.

Other Information: Protect the product in this container from excessive heat and direct sun. For expiration date, please see bottom of jar.

Distributed by 

KEYSTONE LABORATORIES © 2013

www.keystone-labs.com

1-800-772-8860  / Memphis, TN 38101-2026

MADE IN U.S.A.

PM-LB 0011

Inactive Ingredients:

Aqua/Water/Eau, Stearyl Stearate, Glycerol Stearate, Propylene Glycol Alcohol, Isopropyl Myristate, Sodium Metabisulfite, Fragrance, Sodium Sulfite, Steareth 20, Methyl Paraben, Buthydroxytoluene, Propyl Gallate, Tetrasodium EDTA, Propyl Paraben, Citric Acid

ULTRA GLOW FADE 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58318-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE1 g  in 51 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERYL MONOSTEARATE 
SODIUM LAURYL SULFATE 
PROPYLENE GLYCOL 
ISOPROPYL MYRISTATE 
CETYL ALCOHOL 
SODIUM METABISULFITE (BISULFITE ION)  
STEARYL STEARATE 
STEARETH-20 
METHYLPARABEN 
PROPYLPARABEN 
BUTYLATED HYDROXYTOLUENE 
PROPYL GALLATE 
SODIUM SULFITE 
EDETATE DISODIUM 
CITRIC ACID MONOHYDRATE 
METHYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:58318-003-0151 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A01/10/2018
Labeler - Keystone Laboratories (007017429)
Establishment
NameAddressID/FEIOperations
Keystone Laboratories007017429manufacture(58318-003)

 
Keystone Laboratories

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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